Safety evaluation of the food enzyme xylanase from Bacillus pumilus (strain BLXSC)

The food enzyme 1,4-β-d-xylan xylanohydrolase (EC 3.2.1.8) is produced with the non-genetically modified strain Bacillus pumilus (strain BLXSC) by Advanced Enzyme Technologies Ltd. The food enzyme is intended to be used in baking processes, grain treatment for the production of starch and gluten fractions, and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for baking processes. Based on the maximum recommended use levels for baking processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.138 mg TOS/kg body weight (bw) per day. As the production strain of B. pumilus meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use (other than distilled alcohol production), the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but is considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Keywords: 1,4‐β‐d‐xylan xylanohydrolase; Bacillus pumilus; EC 3.2.1.8; endo‐1,4‐β‐xylanase; food enzyme; non‐genetically modified microorganism; xylanase.